Replies to post #8571 on Biotech Values

[DewDiligence]

Re: GERN telomerase vaccine in prostate cancer

Thanks, Urche, for your cogent observations. I do not consider GERN’s vaccine program a threat to anything DNDN is doing.

>>It is interesting to compare the GERN PR spin vs the actual abstract…<<

Yes, GERN is a master of spin --enough spin to keep me from being seriously interested in them as an investment. It may be my loss, but so be it.

[walldiver]

<<5) This abstract reminds me of what has always made me nervous about Provenge---the fact that the vaccine is based on PAP, not a very specific and far from ideal prostate cancer antigen.>>

Are you sure about that? From what DNDN says, PAP is found in approx 95% of prostate cancers, and the only healthy tissue in which it's marked is prostate tissue. As Provenge is designed for patients who have had their prostates removed, to me it seems to be an ideal target.

[DewDiligence]

MRK takes an option on Geron’s telomerase vaccine:

[This is a multi-faceted deal where no financial terms have been disclosed. I think it’s reasonable to infer that the money changing hands now is very small. However, if MRK eventually elects to opt-in later for rights to GERN’s telomerase vaccine, currently being tested in metastatic prostate cancer (#msg-5627546), the monetary consideration will likely be substantial for a company of GERN’s size.]

http://biz.yahoo.com/bw/050718/185287.html?.v=1

>>
Geron Enters into a Collaboration and License Agreement with MERCK & CO., INC. for Cancer Vaccines Targeting Telomerase

Monday July 18, 7:30 am ET

MENLO PARK, Calif.--(BUSINESS WIRE)--July 18, 2005--Geron Corporation (Nasdaq: GERN ) announced today it has entered into a collaboration and license agreement with Merck & Co., Inc. (NYSE: MRK ) to develop a cancer vaccine targeting telomerase utilizing Merck's expertise in vaccine technologies.

Under the terms of the agreement, Geron will receive an upfront payment, milestone payments upon achievement of certain development and regulatory events, and royalties. Merck has also agreed to acquire equity in Geron at a future date as part of Geron's next round of financing. Additional financial terms were not disclosed.

In addition, Merck has acquired an exclusive option to negotiate a separate agreement for Geron's dendritic cell-based telomerase vaccine currently in Phase I/II clinical trials at Duke University Medical Center. Geron will receive an option payment from Merck in consideration for the option. The structure and terms of an agreement for the dendritic cell vaccine will be negotiated should Merck exercise its rights under the option.

"This alliance reflects Merck's recognition of telomerase as an important cancer target and Geron's recognition of the strength of Merck's vaccine platform," said Thomas Okarma, M.D., Ph.D., Geron's president and chief executive officer. "Our decision to collaborate with Merck was an easy one to make. In the course of our discussions, we have been impressed with Merck's focus and commitment to developing cancer vaccines."

Geron and Merck have jointly developed a research and development plan to optimize and expedite the demonstration of efficacy and tolerability of a potential vaccine against telomerase using Merck's platform. Meanwhile, Geron will continue development of its dendritic cell-based vaccine product, which is currently in Phase I/II clinical trials and is the subject of the exclusive option obtained by Merck.

"We at Merck are excited about what Geron has demonstrated with telomerase in cancer. Our objective is to combine our technologies with the hope of bringing a product to market that may have application across a large number of cancers," said Stephen Friend, M.D., Ph.D., executive vice president, Advanced Technology and Oncology at Merck Research Laboratories. "This is a project of high interest and commitment at Merck, and is indicative of Merck's strategic direction in developing new anti-cancer therapies."

Telomerase and Cancer

Telomerase is an enzyme, active in most cancer cells, that maintains telomere length at the ends of chromosomes. This activity confers replicative immortality to the cells in the tumor, allowing the cancer to grow and metastasize over long periods of time. Because telomerase is inactive or only transiently expressed in normal human tissues, and is critical to the growth and progression of most cancer types, it is regarded as a universal and specific cancer target.

Geron Corporation

Geron is a biopharmaceutical company developing and commercializing three groups of products: i) therapeutic products for oncology that target telomerase; ii) pharmaceuticals that activate telomerase in tissues impacted by senescence, injury or degenerative disease; and iii) cell-based therapies derived from its human embryonic stem cell platform for applications in multiple chronic diseases.

Geron has two anti-cancer products in the clinic that target telomerase: GRN163L, a potent and specific telomerase inhibitor drug that has just received clearance from the FDA to begin testing in patients with chronic lymphocytic leukemia (CLL); and GRNVAC1, a telomerase therapeutic vaccine currently in multiple Phase I/II trials at Duke in patients with prostate cancer.

In March, results of the first completed Phase I/II clinical trial at Duke of GRNVAC1 in metastatic prostate cancer patients was published in the Journal of Immunology (JI, 2005, 174:3798-38097). The vaccine protocol successfully generated telomerase specific T-cell responses in 19 of 20 subjects. The vaccine was well tolerated with no major treatment-related toxicities. Peak immune responses to vaccination were remarkably high, with between 1%-2% of circulating CD8+ T-cells demonstrating anti-telomerase specificity. Clinically, vaccination was associated with a statistically significant increase in PSA doubling time and clearance of prostate cancer cells from the patients' blood.
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